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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K182038
Device Name URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
Applicant
Yd Diagnostics Corporation
76, Seori-Ro, Idong-Myeon, Cheoin-Gu
Yongin-Si,  KR 17127
Applicant Contact Hyuckjoo Lee
Correspondent
Ammirati Regulatory Consulting
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika B. Ammirati
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Codes
CEN   JIL   JIN   JIO   JIR  
JMT   JRE   KQO   LJX  
Date Received07/30/2018
Decision Date 12/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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